Effect of Morning Versus Evening Perindopril on Blood Pressure Control in People With Type 2 Diabetes

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2; Hypertension
• Interventions: Drug: Perindopril Oral Tablet

• Registration Number: NCT03393715
• Lead Sponsor: Yaounde Central Hospital

Brief Summary

We assessed the influence of time of administration of ACE inhibitors on circadian blood pressure control in sub Saharan type 2 diabetes patients with stage 1 hypertension over 56 days as first line treatment.

Detailed Description

Background: Renin-angiotensin system antagonists represent the mainstay of blood pressure (BP) lowering treatment options in people with diabetes. ACE inhibitors have a long half-life and offer the advantage of a single daily dose, usually empirically taken in the morning.

Objective: We assessed the influence of time of administration of ACE inhibitors on circadian BP control in type 2 diabetes (T2D) patients with stage 1 hypertension.

Methods: Twenty T2D patients (9 being women) with a mean age of 58.7 years, diagnosed with stage 1 of hypertension and naive to BP lowering medications, were included. They were randomly allocated to receive perindopril 10 mg/day as a monotherapy either in the morning or in the evening for 28 days, with crossover without washout period on day 29th and additional 28 days follow-up. A 24-hour ambulatory BP monitoring (ABPM) was performed at baseline, days 28 and 56.

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Study First Submitted: 2017-12-21
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-05
• Last Update Submitted: 2018-01-05
• Study First Posted: 2018-01-08
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Type 2 diabetes
• Grade 1 hypertension
• Informed consent

Exclusion Criteria

• estimated creatinine clearance≤ 60ml/min
• White coat hypertension after initial 24 hour ABPM
• Previous antihypertensive treatment
• Pregnant women
• Individuals working during the night
• Hyperkalemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Perindopril evening	Perindopril Oral Tablet	10 mg of perindopril oral tablet once daily in the evening for 56 days
Perindopril morning	Perindopril Oral Tablet	10 mg of perindopril oral tablet once daily in the morning for 56 days

Primary Outcome Measures

Name	Time	Method
24-hour blood pressure profile	56 days	Overall blood pressure control

Secondary Outcome Measures

Name	Time	Method
Night time blood pressure dip	56 days	Blood pressure drop at night